Tissue fixation system and method

ABSTRACT

A tissue fixation system is provided for dynamic and rigid fixation of tissue. A fastener connected with an elongate fastening member, such as a cable, wire, suture, rod, or tube, is moved through a passage between opposite sides of tissue. A medical device is used to secure the fastener to the elongate fastening member. The medical device includes a tensioning mechanism for tensioning the elongate fastening member. As crimping mechanism is used to secure the fastener to the elongated member, where a cutting mechanism cut the excess portion of the elongated member.

CROSS-REFERENCE TO RELATED APPLICATION

This Application claims priority to U.S. Provisional Patent ApplicationNo. 60/889,605, entitled Tissue Fixation System and Method, filed onFeb. 13, 2007, the contents of which are incorporated herein byreference in their entirety.

FIELD OF THE INVENTION

The invention relates to a system and method for fixation andstabilization of tissue. In particular, the invention relates tominimally invasive bone fracture fixation and stabilization.

BACKGROUND OF THE INVENTION

It is well-known in the medical arts that applying pressure to tissuehelps during the healing process. Incised or torn soft tissue, forexample, may be approximated with bandages, sutures, or staples. Properand more rapid healing of broken or fractured bones likewise may befacilitated by applying constant pressure to the bone. For instance,physicians may insert pins, screws, or bolts in the area of the fracturein order to apply pressure to the fracture.

However, inserting screws through or around fractures can be complex andtime-consuming. For example, the process of inserting a screw typicallyinvolves multiple steps conducted from multiple incisions or openingsthat provide access to the treated bone or tissue, including the stepsof drilling holes, measuring the relevant distances to determine theappropriate screw selection, tapping the hole to establish threads, andscrewing the screw into the hole.

In addition to the length and complexity of the process, bone screwsalso may lose their grip and strip out of the bone. In addition,currently available lag screws also typically provide only one side ofcortex fixation and are generally not suited for percutaneous surgery.Moreover, when placing the screws in the bone, the physician may notaccurately set the screw into the distal hole or may miss the distalhole completely, thereby resulting in the screw stripping the threads orbreaking the bone.

Many devices and instruments have been disclosed to fasten soft and hardtissue for enhanced healing or tissue reconstruction. Examples of suchdevices include bone plates, bone wraps, external bone supports, and thelike.

For example, U.S. Pat. No. 5,921,986, the contents of which areincorporated herein by reference, discloses a bone suture and associatedmethods for implantation and fracture fixation. The '986 Patentdescribes fasteners and anchors used in conjunction with an elongatefixation element, such as a suture. In some cases, it may beadvantageous to use more rigid fixation elements.

Accordingly, a need exists for a tissue fixation instrument which canprovide flexible or rigid fixation of tissue while accessing the tissuefrom a small skin portal.

SUMMARY OF THE INVENTION

The present invention relates to a tissue fixation system. The systemcomprises an elongate fastening member and a fastener moveable withrespect to the elongate fastening member from a first orientation to asecond orientation, the fastener having a body with a tissue contactingsurface that includes a groove configured and dimensioned to receive aportion of the elongate member in the first orientation. The system canalso include a second fastener or other means for maintaining tension inthe elongate fastening member.

A biasing means can be provided to maintain the fastener in the firstorientation. The biasing means can be an adhesive between the groove andthe portion of the elongate fastening member received in the groove. Thebiasing means could also be a frangible connection between the grooveand the portion of the elongate fastening member received in the groove.

The fastener body can have a free surface opposite the tissue contactingsurface, with the free surface including a channel configured anddimensioned to receive a portion of the elongate member in the firstorientation. The fastener body can also include a through bore extendingfrom the tissue contacting surface through the free surface.

In one embodiment, the fastener body includes leading and trailing ends.The leading end can be tapered or otherwise shaped to facilitateinsertion. The groove terminates at the through bore and extends towardone of the leading and trailing ends and the channel terminates at thethrough bore and extends toward the other of the leading and trailingends. In an exemplary embodiment, the groove extends toward the leadingend and the channel extends toward the trailing end.

The free surface of the fastener body can be provided with a wellsurrounding the through bore. The well can be configured and dimensionedto receive at least a portion of the stop. A distal end of the elongatefastening member can include a stop larger than the through bore.

The present invention also relates to a medical instrument or device forsecuring the fastener with respect to the elongate fastening member. Themedical device tensions the elongate fastening member and crimps eitherthe fastener or a bushing. Another aspect of the invention relates tomethods of tissue fixation using the disclosed tissue fixation systems.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1 shows a schematic illustration of a tissue fixation systemaccording to the present invention utilized for fracture fixation;

FIG. 2 shows a perspective view of a fastener according to the presentinvention;

FIG. 3 shows a side view of the fastener of FIG. 2 ;

FIG. 4 shows a bottom view of the fastener of FIG. 2 ;

FIG. 5 shows a top view of the fastener of FIG. 2 ;

FIG. 6 shows a fastener and elongate fastening member with the fastenerin a first orientation with respect to the elongate fastening member;

FIG. 7 shows a front view of a fastener in the first orientation withrespect to the elongate fastening member with the fastener rotated 180°compared to FIG. 6 ;

FIG. 8 shows a back view of the fastener and elongate fastening memberof FIG. 7 ;

FIG. 9A shows an elongate fastening member according to the presentinvention;

FIG. 9B shows an elongate fastening member including expandable members;

FIG. 10 shows a fastener in a second orientation with respect to anelongate fastening member;

FIG. 11 shows a cannulated drill system used to create a passage throughthe tissue to be fixed;

FIG. 12 shows a sleeve having a lumen through which the fixation systemcan be passed;

FIG. 13 shows a distal fastener being inserted into the sleeve;

FIG. 14 shows a pushrod used to move the distal fastener through thesleeve;

FIG. 15 shows the distal fastener in the second orientation;

FIG. 16 shows a proximal fastener being used to maintain the tension inthe elongate fastening member;

FIG. 17 depicts a front isometric view of a medical device in accordancewith the present invention;

FIG. 18 depicts a sectional view showing the tensioning mechanism of themedical device of FIG. 17 ;

FIG. 19 depicts a side isometric view showing the tensioner housing ofthe medical device of FIG. 17 ;

FIG. 20 depicts an exploded view of the locking assembly of the medicaldevice of FIG. 17 ;

FIG. 21 depicts a rear isometric view of the locking assembly of themedical device of FIG. 17 ;

FIG. 22 depicts an exploded view of the rotation assembly of the medicaldevice of FIG. 17 ;

FIG. 23 depicts partial isometric view of the connection of the rotationassembly of FIG. 22 to the locking assembly of FIG. 21 ;

FIG. 24 depicts a partial front exploded view of the torque controllerof the tensioning mechanism;

FIG. 25 depicts a partial rear exploded view of the torque controller ofthe tensioning mechanism;

FIG. 26 depicts a partial front isometric view of the rotation assemblyof FIG. 22 ;

FIG. 27 depicts a front isometric view of the collet of the medicaldevice of FIG. 17 ;

FIG. 28 depicts a partial sectional view of the crimping mechanism ofthe medical device of FIG. 17 ;

FIG. 29 depicts an partial sectional view of the crimping mechanism ofthe medical device of FIG. 17 ;

FIG. 30 depicts a partial isometric view showing the cutting mechanismof the medical device of FIG. 17 ;

FIG. 31 depicts a partial sectional view showing the cutting mechanismof FIG. 30 ;

FIG. 32 depicts the locking mechanism of the medical device of FIG. 17 ;

FIG. 33 depicts a partial isometric view showing the handle portion ofthe cutting mechanism;

FIG. 34 depicts a safety lock of the medical device of FIGS. 17 ; and

FIG. 35 depicts a stroke limiter of the cutting mechanism.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a tissue fixation system for dynamic andrigid fixation of tissue. The system can be utilized for the fixationand stabilization of body tissue, including soft tissue to soft tissue,soft tissue to bone, and bone to bone. The surgical system canadditionally be used to affix implants and grafts to body tissue. Thesystem can access and treat fractured, incised or torn tissue, or thelike, from one access area (i.e., from only one opening to the tissue tobe fastened) instead of requiring two or more openings. That is, thesystem is a linear fixation system that can be used with a single, smallincision or portal in the skin or other soft tissue to gain access tothe fractured bone. The fixation system may be an all-in-one system,packaged as a system kit, for creating a passage in tissue, positioningfasteners, and tensioning an elongate fastening member, like a suture,thread, cable, wire, rod, or pin. The individual components of thesystem can either be reusable or single use components.

Referring now to the drawing figures in which like reference designatorsrefer to like elements, FIG. 1 shows an exemplary embodiment of a tissuefixation system 100 according to the present invention. A fracturedportion 102 of a bone 104 is approximated by system 100. Use of system100 is not limited to any particular type of fracture. Furthermore, useof system 100 is not limited to fracture fixation. In other words,system 100 can be utilized for other tissue fixation applications (suchas soft tissue) or similar clinical indications. Examples of such tissueincludes, are not limited to, muscle, cartilage, ligament, tendon, skin,etc. Also, the tissue may be stomach tissue, and the system may be usedduring bariatric surgery, as in stomach stapling. Additionally, thesystem 100 can be used for the fixation of implants to tissue.

In this regard, the present invention may be used in conjunction withany surgical procedure of the body. The repair, reconstruction,augmentation, and securing of tissue or an implant may be performed inconnection with surgery of a joint, bone, muscle, ligament, tendon,cartilage, capsule, organ, skin, nerve, vessel, or other body part. Forexample, tissue may be repaired, reconstructed, augmented, and securedfollowing intervertebral disc surgery, knee surgery, hip surgery, organtransplant surgery, bariatric surgery, spinal surgery, anterior cruciateligament (ACL) surgery, tendon-ligament surgery, rotator cuff surgery,capsule repair surgery, fractured bone surgery, pelvic fracture surgery,avulsion fragment surgery, hernia repair surgery, and surgery of anintrasubstance ligament tear, annulus fibrosis, fascia lata, flexortendons, etc. In one particular application, an anastomosis is performedover a balloon and the methods and devices of the present invention areused to repair the vessel.

Also, tissue may be repaired after an implant has been inserted withinthe body. Such implant insertion procedures include, but are not limitedto, partial or total knee replacement surgery, hip replacement surgery,bone fixation surgery, etc. The implant may be an organ, partial organgrafts, tissue graft material (autogenic, allogenic, xenogenic, orsynthetic), collagen, a malleable implant like a sponge, mesh,bag/sac/pouch, collagen, or gelatin, or a rigid implant made of metal,polymer, composite, or ceramic. Other implants include breast implants,biodegradable plates, porcine or bovine patches, metallic fasteners,compliant bearing for medial compartment of the knee, nucleus pulposusprosthetic, stent, tissue graft, tissue scaffold, biodegradable collagenscaffold, and polymeric or other biocompatible scaffold. The scaffoldmay include fetal cells, stem cells, embryonal cells, enzymes, andproteins.

The present invention further provides flexible and rigid fixation oftissue. Both rigid and flexible fixation of tissue and/or an implantprovides compression to enhance the healing process of the tissue. Afractured bone, for example, requires the bone to be realigned andrigidly stabilized over a period time for proper healing. Also, bonesmay be flexibly secured to provide flexible stabilization between two ormore bones. Soft tissue, like muscles, ligaments, tendons, skin, etc.,may be flexibly or rigidly fastened for proper healing. Flexiblefixation and compression of tissue may function as a temporary strut toallow motion as the tissue heals. Furthermore, joints which include hardand soft tissue may require both rigid and flexible fixation to enhancehealing and stabilize the range of motion of the joint. Flexiblefixation and compression of tissue near a joint may provide motion inone or more desired planes. The fasteners described herein andincorporated by reference provide for both rigid and flexible fixation.

Although the invention is described primarily on a macroscopic level, itis also envisioned that the present invention can be used formicroscopic applications. For example, in the repair of nerve tissue,individual cells or fibers may need to be repaired. Similarly, musclerepair may require tightening of individual muscle fibers.

System 100 includes a distal fastener 106 contacting fracture portion102, a proximal fastener 108 contacting bone 104, and an elongatefastening member 110 extending through the fracture and coupling distaland proximal fasteners 106, 108. Tension is maintained in elongatefastening member 110 to press fasteners 106, 108 against opposite sidesof bone 104 with a desired force. This force presses fracture portion102 against bone 104 firmly together to promote healing of the fracture.If desired, buttons or other force distributing members could beprovided between fasteners 106, 108 and the bone. Although FIG. 1 showsdistal and proximal fasteners 106, 108 as having the same construction,they could have differing construction. However, for convenience andpractical purposes, it may be beneficial if distal and proximalfasteners 106 and 108 have substantially the same construction.

FIGS. 2-5 show an exemplary embodiment of a fastener 112 that can beused as part of system 100, i.e. as either or both of distal andproximal fasteners 106, 108. Fastener 112 has a body 114 that isconfigured and dimensioned to facilitate implantation through minimallyinvasive procedures, e.g. through a cannula or sleeve. In particular,body 114 includes a tissue contacting surface 116 that is provided withgroove 118 that receives a portion of elongate fastening member 110 whenfastener 112 is in a first orientation with respect to elongatefastening member 110. This is seen in FIG. 6 . The accommodation ofelongate fastening member 110 within groove 118 helps to minimize theprofile of the assembly of fastener 112 and elongate fastening member110. The reduced profile can be more readily passed through a cannula orsleeve. If desired, an adhesive can be provided within groove 118 tobias fastener 112 in the first orientation. Alternatively, a frangibleconnection can be provided between groove 118 and a portion of elongatefastening member 110, operative to keep fastener 112 in the firstorientation with respect to elongate fastening member 110, until thefrangible connection is broken, when desired.

Fastener 112 is provided with first and second ends 120, 122. As shownin FIG. 6 , first end 120 is the leading end and second end 122 is thetrailing end. In this position, when fastener 112 is pivoted to a secondorientation, like distal fastener 106 of FIG. 1 , tissue contactingsurface 116 is in contact with the tissue. As shown in FIGS. 7 and 8 ,second end 122 is the leading end and first end 120 is the trailing end.In this position, when fastener 112 is pivoted to the secondorientation, like proximal fastener 108 of FIG. 1 , tissue contactingsurface 116 is in contact with the tissue.

Fastener body 114 has a free surface 124 opposite tissue contactingsurface 116. Free surface 124 is provided with a channel 126 thatreceives a portion of elongate fastening member 110 when fastener 112 isin a first orientation with respect to elongate fastening member 110. Asshown in FIGS. 7 and 8 , fastener 112 is being slid along elongatefastening member 110. In particular, a through bore 128 extends fromtissue contacting surface 116 through free surface 124. Through bore 128is larger in diameter than elongate fastening member 110 so thatfastener 112 freely slides along elongate fastening member 110. Aportion of elongate fastening member 110 fits within channel 126 on freesurface 124 and a portion of elongate fastening member 110 fits withingroove 118 on tissue contacting surface 116.

Fastener body 114 is shown with first end 120 having a substantiallyflat profile and second end 122 having a tapered profile. In general,any suitable external configuration can be used for fastener 112.Examples of fasteners may be found in U.S. Pat. Nos. 5,163,960;5,403,348; 5,464,426; 5,549,630; 5,593,425; 5,713,921; 5,718,717;5,782,862; 5,814,072; 5,814,073; 5,845,645; 5,921,986; 5,948,002;6,010,525; 6,045,551; 6,159,234; 6,368,343; 6,447,516; 6,475,230;6,592,609; 6,635,073; and 6,719,765. Other fastener types are disclosedin U.S. patent application Ser. Nos. 10/102,413; 10/228,855; 10/779,978;10/780,444; 10/797,685, and 11/358,331. The above cited patents andpatent applications are hereby incorporated by reference.

Fastener 112 can be made of any biocompatible material suitable for agiven application. For example, the fasteners may be, but are notlimited to, degradable, biodegradable, bioerodible, bioabsorbable,mechanically expandable, hydrophilic, bendable, deformable, malleable,riveting, threaded, toggling, barbed, bubbled, laminated, coated,blocking, pneumatic, one-piece, multi-component, solid, hollow,polygon-shaped, pointed, self-introducing, and combinations thereof.Also, the fasteners may include metallic material, polymeric material,ceramic material, composite material, body tissue, synthetic tissue,hydrophilic material, expandable material, compressible material, heatbondable material, and combinations thereof. Examples of body tissueinclude bone, collagen, cartilage, ligaments, or tissue graft materiallike xenograft, allograft, and autograft. The fasteners may also be madefrom a porous matrix or mesh of biocompatible and bioresorbable fibersacting as a scaffold to regenerate tissue.

The fasteners may further be made of or have a coating made of anexpandable material. The material could be compressed then allowed toexpand. Alternatively, the material could be hydrophilic and expand whenit comes in contact with liquid. Examples of such expandable materialsare ePTFE and desiccated body tissue.

Moreover, the fasteners described herein and incorporated by referencemay include therapeutic substances to promote healing. These substancescould include antibiotics, hydroxyapatite, anti-inflammatory agents,steroids, antibiotics, analgesic agents, chemotherapeutic agents, bonemorphogenetic protein (BMP), demineralized bone matrix, collagen, growthfactors, autogenetic bone marrow, progenitor cells, calcium sulfate,immo suppressants, fibrin, osteoinductivc materials, apatitecompositions, germicides, fetal cells, stem cells, enzymes, proteins,hormones, cell therapy substances, gene therapy substances, andcombinations thereof. These therapeutic substances may be combined withthe materials used to make the fasteners to produce a compositefastener. Alternatively, the therapeutic substances may be impregnatedor coated on the fastener. Time-released therapeutic substances anddrugs may also be incorporated into or coated on the surface of thefastener. The therapeutic substances may also be placed in abioabsorbable, degradable, or biodegradable polymer layer or layers.

FIG. 9A shows an exemplary embodiment of an elongate fastening member130. Elongate fastening member 130 includes a body 132 and has a stop134 at a distal end. Body 132 can be selected for a given application.For example, if a rigid elongate fastening member 130 is needed, body132 can be a rod or a tube. If a more flexible elongate fastening member130 is needed, body 132 can be a suture. In general, a wire analogous tothose used for cerclage of bone fractures is believed to provide asuitable combination of strength and flexibility. Although body 132 isshown as a single strand wire, the invention can be used with any typeof surgical cable, such as a multi-strand cable.

Stop 134 can be made integral with body 132 or separate and thenattached. Stop 134 is larger in diameter than through bore 128 in body114 of fastener 112. Thus, once stop 134 reaches through bore 128,fastener 112 cannot be slid any further along elongate fastening member130. As shown in FIG. 5 , free surface 124 of fastener 112 is providedwith a well 136 surrounding through bore 128. Well 136 is configured anddimensioned to receive at least a portion of stop 134. As shown in FIG.10 , this helps reduce the profile of the assembly when fastener 112 isin a second orientation with respect to elongate fastening member 130.

Referring to FIG. 9B, in another embodiment, the elongated fastenermember 130 includes expandable members 131, positioned along the body132. Upon insertion into the tissue, the expandable members 131 expandto engage the surrounding tissue. For examples, the expandable members131 can be barbs. The barbs 131 engage the surrounding tissue,maintaining elongated fastener member's 130 position within the tissue.

The elongate fastening members of the present invention may be made ofmetallic material, non-metallic material, composite material, ceramicmaterial, polymeric material, co polymeric material, or combinationsthereof. The members may be degradable, biodegradable, bioabsorbable, ornonbiodegradable. Examples of suture materials that can be used for theelongate fastening members are polyethylene, polyester, cat gut, silk,nylon, polypropylene, linen, cotton, and copolymers of glycolic andlactic acid. Preferably, the members are flexible or bendable. They maybe threadlike, monofilament, multifilament, braided, or interlaced. Themembers may have a coating of therapeutic substances or drugs. Forexample, the members may include antibiotics, hydroxyapatite,anti-inflammatory agents, steroids, antibiotics, analgesic agents,chemotherapeutic agents, bone morphogenetic protein, demineralized bonematrix, collagen, growth factors, autogenetic bone marrow, progenitorcells, calcium sulfate, immo suppressants, fibrin, osteoinductivematerials, apatite compositions, fetal cells, stem cells, enzymes,proteins, hormones, and germicides.

The use of the tissue fixation system according to the present inventionwill now be described using fracture fixation as an example. Ifnecessary, the fracture is reduced bringing fracture portion 102 intocontact with bone 104 (FIG. 11 ). The reduction can be achieved usingany number of techniques.

As also shown in FIG. 11 , a drill system 138 is used to drill acrossthe fracture, thereby creating a passage completely through bone 104.Drill system 138 includes a drill bit 140 with a headpiece configuredfor attachment to a drill. A drill stop can be placed on the headpieceand prevents drill bit 140 from penetrating too far beyond the tissue tobe drilled. Drill system 138 may be a cannulated drill system that fitsover a k-wire or other similar guide wire. A cannula or sleeve 142 mayencircle drill bit 140 or at least the shaft portion of drill bit 140.As drill bit 140 creates a passage through bone 104, sleeve 142 ispositioned in the passage. Drill system 138 is used to create a passagein bone 104 from the proximal side of bone 104 to the distal side ofbone 104, then the drill and drill bit 140 are removed from sleeve 142(FIG. 12 ).

As shown in FIG. 13 , a distal fastener 112 a is inserted into sleeve142. Distal fastener 112 a is inserted in the first orientation withrespect to elongate fastening member 130 with first end 120 as theleading end. In this configuration, tissue contacting surface 116 willbe in contact with fracture portion 102 when distal fastener 112 a ispivoted into the second orientation. This is best seen in FIGS. 14 and15 , in which a pushrod 144 is used to advance distal fastener 112 a andelongate fastening member 130 through sleeve 142. Pushrod 144 alsofacilitates the pivoting of distal fastener 112 a from the firstorientation to the second orientation. This pivoting is not possibleuntil distal fastener 112 a has exited through sleeve 142. Also, becausethe length of distal fastener 112 a is larger than the passage createdin bone 104, pulling back on elongate fastening member 130 helps toensure distal fastener 112 a is in the second orientation and flushagainst fracture portion 102.

As illustrated in FIG. 16 , sleeve 142 is removed from bone 104.Fastener 112 a is located on the distal side of bone 104. Elongatefastening member 130 extends from fastener 112 a through the bonepassage and out the proximal opening of the bone or tissue passage. Anysuitable means can be used to keep distal fastener 112 a againstfracture portion 102 with tension, where the tension can be measure andcontrolled in accordance with use. For example, elongate fasteningmember 130 can be deformed at the proximal end of the passage such thatthe deformed section rests against bone 104. The deformation woulddepend on the nature of elongate fastening member 130. If elongatefastening member 130 is a relatively flexible element, such as a suture,cable, or wire, then simply tying a knot in fastening member 130 couldbe sufficient to maintain the tension. If elongate fastening member 130does not allow a knot, such as would be the case with a rod or tube,then mechanical deformation of elongate fastening member 130 to createan enlarged head could be sufficient to maintain the tension. U.S.Patent Application Publication No. US 2002/0016593, the contents ofwhich are incorporated herein by reference, discloses mechanisms tomechanically deform an extension member and could be used to deformelongate fastening member 130.

Alternatively, the elongated fastening member 130 can be deformed by anenergy source, such as thermal energy, to deform elongate fasteningmember 130 to create an enlarged head sufficient to maintain thetension.

In an exemplary embodiment, a proximal fastener 112 b is used to securedistal fastener 112 a and elongate fastening member 130. In thisembodiment, proximal fastener 112 b is identical to distal fastener 112a. If not already pre-loaded, proximal fastener 112 b is loaded ontoelongate fastening member 130. Proximal fastener 112 b is loaded asshown in FIGS. 7 and 8 , i.e. with second end 122 as the leading end sothat after proximal fastener 112 b is slid down against bone 104 andpivoted into the second orientation, tissue contacting surface 116 is incontact with bone 104.

Elongate fastening member 130 is tensioned, and proximal fastener 112 bis secured to elongate fastening member 130 to thereby approximate thefracture and stabilize bone 104. The tension of elongate fasteningmember 130 pulls on distal and proximal fasteners 112 a, 112 b generallytoward each other, thereby applying pressure to the fractured bone ortissue. In this regard, a bushing 146 can be used to secure proximalfastener 112 b with the desired tension. Single or multiple elongatedmembers 130 can be used to secure the fractured bone or tissue.

Although a number of mechanisms can be used to secure bushing 146, aninstrument or medical device particularly useful for this will now bedescribed.

In this regard, the present invention also provides a medical device forsecuring a fastener against relative movement with respect to a cable.As previously disclosed, a cable and pair of oppositely spaced fastenerscan be used to secure a bone fracture. The cable is passed through thebone and fracture; a first fastener secures the cable on a first side(fracture side) of the bone; and a second fastener is positioned aboutthe cable on a second side of the bone, opposite the first fastener. Abushing is positioned onto the cable to secure the second fasteneragainst the second side of the bone. A force is applied to the bushing,compressing the second fastener against the second side of the bone andproviding a tension to the cable. The tension in the cable can bemeasured and controlled, for example, with the use of a sensor andspring element. The spring can apply the force to tension the cable, andthe sensor can be used to measure the resulting tension. Alternatively,the sensor can measure the compression of the tissue to determine thetension. The bushing is crimped about the cable, securing the secondfastener against the second side of the bone, such that a tension isprovided through the cable between the first and second fasteners.

Referring now to FIG. 17 , a medical device 200 in accordance with anembodiment of the invention is provided for securing the bushing to thecable. Medical device 200 includes handle portion 202 having atensioning mechanism 204, operative to tension cable 110/132 and apply aforce to bushing 146, and a crimping mechanism 206 operative to securingbushing 146 to cable 110 or 132 of system 100 or member 130.

With additional reference to FIG. 18 , tensioning mechanism 204 includescollet holder 208 defining a longitudinal passage along a centrallongitudinal axis A-A. Collet holder 208 is fixedly positioned throughtop portion 212 of handle portion 202, secured by collet holder pin 214.A cable tensioner 216 is positioned proximal to a first end 218 of thecollet holder 208. Cable tensioner 216 includes rotatable shaft 220aligned with the longitudinal passage of the collet holder 208.Rotatable shaft 220 includes a cable aperture 222 (visible in FIGS.20,21 ) for threading the cable therethrough, wherein cable 132 iswrapped about rotatable shaft 220 to thereby prevent relative movementbetween cable 132 and cable tensioner 216.

Referring to FIG. 19 , tensioner housing 226 is affixed to first portion228 of handle portion 202. Tensioner housing 226 includes recess 230,configured for receiving tensioning assembly 232 of cable tensioner 216,wherein rotatable shaft 220 extends through center hole 231 in tensionerhousing 226.

Referring to FIGS. 20 and 21 , tensioning assembly 232 includes lockingassembly 234. Locking assembly 234 includes inner housing 238, which ispress fit into recess 230 of tensioner housing 226 when assembled. Innerhousing 238 is sized and dimensioned to prevent rotation of innerhousing 238 with respect to tensioner housing 226. Output shaft 240 ispositioned partly within inner housing 238, and includes rotatable shaft220 and shaft head 242. Output shaft 240 is positioned such thatrotatable shaft 220 is extended through center hole 231 in tensionerhousing 226, and shaft head 224 is positioned within inner housing 238.

Roller bearings 246 are positioned between an outer raised surface 248of shaft head 242 and inner surface 250 of the inner housing 238. Theroller bearings 246 are fitted between shaft head 242 and inner housing238, to allow rotation of output shaft 240 with respect to inner housing238.

Outer raised surface 248 of shaft head 242 is provided in asubstantially triangular configuration, having, in the embodiment shown,three sets of pairs of oppositely inclined surfaces, as represented bysurfaces 247,249. Roller bearings 246 are positioned, one each, betweeninclined surfaces 247,249 and inner surface 250 of inner housing 238,such that a rotation of shaft head 250 will pinch or compress rollerbearings 246 between inclined surfaces 247,249 and inner surface 250. Inthis manner, shaft head 242 and output shaft 240 become rotationallylocked together, and are mutually prevented from rotating with respectto inner housing 238. As such, no external torsional force is requiredto produce a locking coupling. In either direction of rotation,clockwise or counter clockwise, at least three roller bearings 246 willbe pinched, locking shaft head 242 and output shaft 240 from rotationalmovement.

Inner extensions 254 of cam plate 252 are positioned between innersurface 250 of inner housing 238 and shaft head 242. Inner extensions254 include raised portions 256 configured to engage notched sections258 of shaft head 242, locking the cam plate 252 to output shaft 240,such that rotation of cam plate 252 will rotate output shaft 240. Inthis manner, cam plate 252 is rotationally coupled to output shaft 240.

Inner extensions 254 are further operative to unlock shaft head 242 andoutput shaft 240. Specifically, when cam plate 252 is rotated, innerextensions 254 dislodge and prevent pinching of roller bearings 246,thus allowing rotation of shaft head 242 and output shaft 240. Whenrotation of cam plate 252 in discontinued, roller bearings 246 willagain be allowed to be pinched, locking shaft head 242 and output shaft240.

Cam plate 252 further includes radial flange 260 disposed about an outercircumference. Retaining ring 262 is positioned over cam plate 252,engaging flange 260 and affixed to tensioner housing 226. In thismanner, cam plate 252, output shaft 240, roller bearings 246, and innerhousing 238 are secured within recess 231 of tensioner housing 226 byretaining ring 262. Engagement of flange 260 and retaining ring 262secures cam plate 252 in position, yet allows for rotation of cam plate252 with respect to tensioner housing 226.

Referring to FIG. 22 , tensioning assembly 232 further includes rotationassembly 236. Rotation assembly 236 includes winding knob 270 definingknob recess 272. Biasing member 274 is positioned in knob recess 272,where compression plate 276 is positioned over biasing member 274.Locking collar 278 is positioned through the bottom of winding knob 270,extending through biasing member 274 such that extensions 280 of lockingcollar 278 are positioned in alignment holes 282 of compression plate276.

Referring also to FIG. 23 , rotation assembly 236 is affixed to lockingassembly 234 by attachment of locking collar 278 to cam plate 252.Locking collar 278 is positioned to overlap upper collar portion 284 ofcam plate 252, wherein upper collar portion 284 extends through lockingcollar 278. Flanged portion 286 of locking collar 278 is affixed to topsurface 287 of cam plate 252. Locking collar 278 can be affixed to camplate 252 with screws, rivets, welding, or other mechanical or chemicalmeans.

The combined locking collar 278 and upper collar portion 284 of camplate 252 extend through the bottom of winding knob 270, extendingthrough biasing member 274 and engaging alignment holes 282 ofcompression plate 276. An adjustment bolt 288 is positioned throughcompression plate 276, threadably engaging threaded hole 289 (notvisible) in cam plate 252, securing rotation assembly 236 to lockingassembly 234.

Connection of rotation assembly 236 to locking assembly 234 includes anautomatic torque control. Referring to FIGS. 24 and 25 , top surface 287of cam plate 252 includes a plurality of raised radial sections 292.Bottom surface 294 of winding knob 270 includes a plurality of matingnotched sections 296 (not visible), one for each of the raised radialsections 292 of cam plate 252. Raised radial sections 292 and notchedsection 296 are configured to engage each other, whereby rotation ofwinding knob 270 will cause engagement of sections 292,296 to causerotation of cam plate 252.

Winding knob 270 is urged into engagement with cam plate 252 by biasingmember 274. Force applied by biasing member 274 can be controlled byrotating adjustment bolt 288. Tightening of adjustment bolt 288 urgescompression plate 276 onto biasing member 274, increasing force appliedbetween them. Loosening of adjustment bolt 288 raises compression plate276 away from biasing member 274, decreasing applied force.

In use, biasing member 274 applies force to winding knob 270, forcingwinding knob 270 into engagement with cam plate 252. Applied force istranslated to a desired tension in cable 132. Torsional force is appliedto winding knob 270 during rotation of winding knob 270, wrapping cable132 about rotatable shaft 220, increasing tension in cable 132. Attensions less than a desired tension, applied force is sufficient tomaintain engagement between winding knob 270 and cam plate 252.

However, at tensions greater then a desired tension, applied force isinsufficient to maintain engagement between winding knob 270 and camplate 252. As such, as an increased torque is applied to winding knob270, winding knob 270 and cam plate 252 will lose engagement, whereinnotched sections 296 of winding knob 270 will skip over raised radialsections 292 of cam plate 252. In this manner, tension greater then adesired tension cannot be applied to cable 132. Furthermore, lockingassembly 234 prevents reversing, or backing off of cam plate 252, thusmaintaining tension in cable 132.

Referring to FIG. 26 , cover plate 297 can be positioned over andaffixed to compression plate 276 cover plate 297 can include limit stop298, for limiting maximum allowable tension on cable. Thumb cap 300 canbe attached to the head of adjustment bolt 288 to facilitate adjustment.Thumb cap 300 is designed to engage limit stop 298, thus preventing anover adjust of adjustment bolt 288.

Cover plate 297 can include tension indicating markings to indicatedesired tension to be applied to cable 132. Thumb cap 300 is rotated toa desired tension, as indicated by the markings, enabling a user toselect a desired tension based on cable strength, or may be used toprevent over tensioning or snapping of cable 132.

Referring to FIGS. 18 and 27 , collet 310 is affixed to second endportion 312 of collet holder 208, opposite cable tensioner 216. Collet310 defines a collet passage longitudinally aligned with thelongitudinal passage of collet holder 208, along central longitudinalaxis A-A. An end portion of collet 310 is bisected, forming first andsecond collet arms 314 and 316. Gap portion 318 is provided betweenfirst and second collet arms 314 and 316. Each of first and secondcollet arms 314 and 316 include force application end portions 320 and322. force application end portions 320 and 322, combine to form bushingaperture 324 configured to received bushing 146 therein. Collet 310 ismade of a semi-rigid material, such that first and second collet arms314 and 316 can be moved from an open to closed position, closing gap318 and bushing aperture 324 between force application end portions 320and 322.

In use, tensioning mechanism 204 is used to tension cable 132. Asdiscussed above, cable 132 can include single or multiple filaments.Cable 132 is inserted through medical device 200 along centrallongitudinal axis A-A, through collet 310, collet holder 208, and cabletensioner 216, positioning bushing in bushing aperture 324 and extendingcable through cable aperture 222. To tension cable, winding knob 270 isrotated until a desired tension is achieved. Desired tension can beselected by setting thumb cap 300 to the desired tension marking.

Referring again to FIGS. 17 and 28 , crimping mechanism 206 includes anouter tube 330 slideably positioned over collet holder 208. Outer tube330 includes first end 332 operably connected to trigger 334 and secondend 336 connected to collet closer 338. Trigger 334 is pivotally mountedin handle portion 202, such that trigger 334 can be actuated from firsttrigger position TR1 to second trigger position TR2. With additionalreference to FIG. 32 , locking mechanism 370 can be included, inaccordance with one embodiment of the invention, which prevents trigger334 from being accidentally actuated. Locking mechanism 370 isdisengaged by rotating it away from handle, where locking mechanism 370is secured to trigger with locking pawl 371.

With reference to FIG. 28 , operable connection between first end ofouter tube 332 and trigger 334 includes an outer tube ferrule engagementmember 342 slidably positioned about collet holder 208 and engagingfirst end 332 of outer tube 330. Tube bias member 344 is interposedbetween handle portion 202 and outer tube ferrule 332, such that tubebias member 344 biases outer tube ferrule 332 and outer tube 330 into afirst tube position P1 (FIG. 29 ). An upper trigger portion 346 includesfirst edge 348, where first edge 348 engages outer tube ferruleengagement member 342 when trigger 334 is actuated from first triggerposition TR1 to second trigger position TR2.

First edge 348 engagement of outer tube ferrule 332 moves outer tubeferrule 332 and outer tube 330 along collet holder 208 from a first tubeposition P1 to a second tube position P2. As trigger 334 is released,tube bias member 344 biases outer tube ferrule 332 and outer tube 33from second tube position P2 to first tube position P1. Simultaneously,trigger 334 is moved to first trigger position TR1.

Referring to FIGS. 17 and 29 , collet closer 338 is positioned on outertube 330 proximal to the force application end portions 320 and 322 offirst and second collet arms 314 and 316. As outer tube 330 is movedfrom first tube position P1 to second tube position P2, collet closer338 is moved over force application end portions 320 and 322. Colletcloser 338 includes inner tapered surfaces 350, such that inner taperedsurfaces 350 applies compressive force to force application end portions320 and 322 together as collet closer 338 is moved over forceapplication end portions 320 and 322, thus closing gap 318 therebetween.

In use, trigger 334 is actuated from first trigger position TR1 tosecond trigger position TR2. Actuation of trigger 334 slides outer tube330 along collet holder 208 from first tube position P1 to second tubeposition P2, moving collet closer 338 along force application endportions 320 and 322 of first and second collet arms 314 and 316. Innertapered surfaces 350 of collet closer 330 apply compressive forces tofirst and second force application end portions 320 and 320, closing gap318 and reducing bushing aperture 324 therebetween. Trigger 334 isreleased, allowing tube bias member 344 to bias outer tube 330 fromsecond tube position P2 to first tube position P1, moving collet closer338 away from force application end portions 320 and 322.

Collet aperture 324 is configured to receive a cable 110/132 asdescribed herein. In general, collet aperture 324 can be configured toreceive any fastener body. Examples of alternative collet apertureconfigurations may be found U.S. patent application Ser. No. 11/358,331,contents of which are hereby incorporated by reference

Referring to FIGS. 30-31 , crimping mechanism 206 can, in accordancewith the invention, further include a cutting mechanism. In oneembodiment, a cutting mechanism includes a pair of cut off cams 352positioned in collet gap 318. Cut of cams 352 each include pin hole 351such that a pin is inserted through collet 310 and each of cut of cams352, pivotally connecting cut off cams 352 to collet 310. Cut off cams352 each include cutting edges 353 for cutting cable. A pair of wedges354 are slidingly positioned along and on opposite sides of collet 310and collet holder 208. Each of wedges 354 include tapered ends 356positioned proximal to cut off cams 352, such that when wedges are movedfrom first wedge position W1 to second wedge position W2, tapered ends356 compress cut off cams 350 together, cutting cable 132. Biasingmember 355 is positioned about the end of cut-off cams 357, biasingcutting edges 353 in an open position. End portions 357 can includenotched section 359 for retaining biasing member 355 thereon. Biasingmember 355 can be a circular nitinol spring, however any elastic memberwill due.

With reference to FIG. 33 , handle 202 further includes wedge pusher 358slidingly positioned about collet holder 208, adjacent to second ends ofwedges 354. Wedge pusher 358 is slidable from a first position to asecond position, such that wedges 354 are moved from a first wedgeposition W1 to a second wedge position W2.

Rocker 360 is pivotally connected to handle 202, such that an actuationof rocker 360 from first rocker position R1 to second rocker positionR2, slides wedge pusher 358 from first position to second position,moving wedges 354 from first wedge position W1 to second wedge positionW2.

Referring to FIGS. 32-34 , locking mechanism 370 includes rocker kicker372 pivotally affixed therein. Rocker kicker 372 is biasedly connectedto locking mechanism 370, being held in a closed position by pin 374.When trigger 334 is actuated from first trigger position TR1 to secondtrigger position TR2, release 376 engages pin 374, releasing rockerkicker 372.

When trigger 334 is released, trigger 334 is allowed to move from secondtrigger position TR2 to first trigger position TR1. To actuate cuttingcams 352, trigger 334 is again moved from first trigger position TR1 tosecond trigger position TR2, such that rocker kicker 372 engages rocker360, pivoting rocker 360 from first rocker position R1 to second rockerposition R2. Rocker 360 slides wedge pusher 358 from first position tosecond position, moving wedges 354 from first wedge position W1 tosecond wedge position W2, such that, tapered ends 356 urge cut off cams352 together, whereupon a cable 132 may be cut. Trigger 334 can then bereleased, releasing the crimped fastener 100.

Referring to FIG. 35 , a cutting mechanism in accordance with anembodiment of the invention further includes a stroke limiter to preventoverdriving of the cut of cams 352. The stroke limiter includes setscrew 380 threadably positioned in threaded hole 382 through lowerportion of rocker 360 set screw 380 is positioned such that back end ofset screw 380 extends from rocker 360. When rocker 360 is actuated, theback end 384 of set screw contacts contacting surface 386 in handle 20,thus limiting travel of rocker 360 and wedges 354, to thereby limitcompression of cutting edges 353. Set screw 380 can be adjusted toadjust maximal compression of cutting edges 353, thereby preventoverdriving of cut off cams 352.

In a method of use in accordance with the invention, cable 132 is passedthrough bone 104 and fracture 102, where first fastener 112 a securescable 132 on first side (fracture side) of bone and second fastener 112b is positioned about cable on second side of bone, opposite firstfastener 112 a. Bushing 146 is positioned onto cable 132 to securesecond fastener 112 a against second side of bone 104.

Cable 132 is inserted through medical device 200 along centrallongitudinal axis “A-A”, through collet 310, collet holder 208, andcable tensioner 216, positioning bushing in bushing aperture 324 andextending cable through cable aperture 222. To tension cable, windingknob 270 is rotated until desired tension is reached. Prior to use,desired tension can be set by rotating thumb cap 300 to a tensionindicated on cover plate 297.

Trigger 334 is actuated from first trigger position TR1 to secondtrigger position TR2. Actuation of trigger 334 slides outer tube 330along collet holder 208 from first tube position P1 to second tubeposition P2, moving collet closer 338 about force application endportions 320 and 322 of first and second collet arms 314 and 316. Innertapered surfaces 356 of collet closer 338 apply compressive forces tofirst and second force application end portions 320 and 322, compressingfirst and second force application end portions 320 and 322 aboutbushing 146 positioned in bushing aperture 324. Compressive forces crimpbushing about cable 132, securing bushing 146 to cable 132.

Simultaneously, actuation of trigger 334 results in rocker 360 engagingwedge pusher 358, sliding wedge pusher 358 and wedges 354 along colletholder 208. Tapered ends 356 of wedges 354 engage cut off cams 352,forcing cutting edge 353 into cable 132, cutting cable 132.

The components of the medical device 200 of the present invention arerigid members made of, for example, aluminum, stainless steel,polymeric, composite materials, or combinations thereof. The componentsare sufficiently rigid to transmit the necessary forces. It should beunderstood that any material of sufficient rigidity might be used. Forexample, some components can be made by injection molding. Generally,for injection molding, tool and die metal molds of the components areprepared. Hot, melted plastic material is injected into the molds. Theplastic is allowed to cool, forming components. The components areremoved from the molds and assembled.

Furthermore, it is contemplated that the components can be made ofpolymeric or composite materials such that the device can be disposable.For example, at least some or all of the components can be made of abiodegradable material such as a biodegradable polymer. Among theimportant properties of these polymers are their tendency todepolymerize relatively easily and their ability to form environmentallybenign byproducts when degraded or depolymerized. One such biodegradablematerial is poly (hydroxyacids) (“PHA's”) such as polyactic acid (“PLA”)and polyglycolic acid (“PGA”).

Additionally, the device can be made of a nonmagnetic material. In suchan instance, the device can be used as a positioning device for use inimaging devices, such as an MRI device. It is also contemplated that thesystem and medical device of the present invention may be disposable ormay be sterilized after use and reused.

The methods and devices of the present invention may be used inconjunction with any surgical procedure of the body. The repair,reconstruction, augmentation, and securing of tissue or an implant maybe performed in connection with surgery of a joint, bone, muscle,ligament, tendon, cartilage, capsule, organ, skin, nerve, vessel, orother body part. For example, tissue may be repaired, reconstructed,augmented, and secured following intervertebral disc surgery, kneesurgery, hip surgery, organ transplant surgery, bariatric surgery,spinal surgery, anterior cruciate ligament (ACL) surgery,tendon-ligament surgery, rotator cuff surgery, capsule repair surgery,fractured bone surgery, pelvic fracture surgery, avulsion fragmentsurgery, hernia repair surgery, and surgery of an intrasubstanceligament tear, annulus fibrosis, fascia lata, flexor tendons, etc. Inone particular application, an anastomosis is performed over a balloonand the methods and devices of the present invention are used to repairthe vessel.

Also, tissue may be repaired after an implant has been inserted withinthe body. Such implant insertion procedures include, but are not limitedto, partial or total knee replacement surgery, hip replacement surgery,bone fixation surgery, etc. The implant may be an organ, partial organgrafts, tissue graft material (autogenic, allogenic, xenogenic, orsynthetic), collagen, a malleable implant like a sponge, mesh,bag/sac/pouch, collagen, or gelatin, or a rigid implant made of metal,polymer, composite, or ceramic. Other implants include biodegradableplates, porcine or bovine patches, metallic fasteners, compliantbearings for one or more compartments of the knee, nucleus pulposusprosthetic, stent, tissue graft, tissue scaffold, biodegradable collagenscaffold, and polymeric or other biocompatible scaffold. The scaffoldmay include fetal cells, stem cells, embryonal cells, enzymes, andproteins.

The present invention further provides flexible and rigid fixation oftissue. Both rigid and flexible fixation of tissue and/or an implantprovides compression to enhance the healing process of the tissue. Afractured bone, for example, requires the bone to be realigned andrigidly stabilized over a period time for proper healing. Also, bonesmay be flexibly secured to provide flexible stabilization between two ormore bones. Soft tissue, like muscles, ligaments, tendons, skin, etc.,may be flexibly or rigidly fastened for proper healing. Flexiblefixation and compression of tissue may function as a temporary strut toallow motion as the tissue heals. Furthermore, joints which include hardand soft tissue may require both rigid and flexible fixation to enhancehealing and stabilize the range of motion of the joint. Flexiblefixation and compression of tissue near a joint may provide motion inone or more desired planes. The fasteners described herein andincorporated by reference provide for both rigid and flexible fixation.

It is contemplated that the devices and methods of the present inventionbe applied using minimally invasive incisions and techniques to preservemuscles, tendons, ligaments, bones, nerves, and blood vessels. A smallincision(s) may be made adjacent the damaged tissue area to be repaired,and a tube, delivery catheter, sheath, cannula, or expandable cannulamay be used to perform the methods of the present invention. U.S. Pat.No. 5,320,611 entitled, Expandable Cannula Having Longitudinal Wire andMethod of Use, discloses cannulas for surgical and medical useexpandable along their entire lengths. The cannulas are inserted throughtissue when in an unexpanded condition and with a small diameter. Thecannulas are then expanded radially outwardly to give a full-sizeinstrument passage. Expansion of the cannulas occurs against theviscoelastic resistance of the surrounding tissue. The expandablecannulas do not require a full depth incision, or at most require only aneedle-size entrance opening.

Also, U.S. Pat. Nos. 5,674,240; 5,961,499; and 6,338,730 disclosecannulas for surgical and medical use expandable along their entirelengths. The cannula has a pointed end portion and includes wires havingcores which are enclosed by jackets. The jackets are integrally formedas one piece with a sheath of the cannula. The cannula may be expandedby inserting members or by fluid pressure. The cannula is advantageouslyutilized to expand a vessel, such as a blood vessel. An expandablechamber may be provided at the distal end of the cannula. The abovementioned patents are hereby incorporated by reference.

In addition to using a cannula with the methods of the presentinvention, an introducer may be utilized to position fasteners at aspecific location within the body. U.S. Pat. No. 5,948,002 entitledApparatus and Method for Use in Positioning a Suture Anchor, disclosesdevices for controlling the placement depth of a fastener. Also, U.S.patent application Ser. No. 10/102,413 discloses methods of securingbody tissue with a robotic mechanism. The above-mentioned patent andapplication are hereby incorporated by reference. Another introducer orcannula which may be used with the present invention is the VERSASTEP®System by TYCO® Healthcare.

The present invention may also be utilized with minimally invasivesurgery techniques disclosed in U.S. patent application Ser. No.10/191,751 and U.S. Pat. Nos. 6,702,821 and 6,770,078. These patentdocuments disclose, inter alia, apparatus and methods for minimallyinvasive joint replacement. The femoral, tibial, and/or patellarcomponents of a knee replacement may be fastened or locked to each otherand to adjacent tissue using fasteners disclosed herein and incorporatedby reference. Furthermore, the methods and devices of the presentinvention may be utilized for repairing, reconstructing, augmenting, andsecuring tissue or implants during and “on the way out” of a kneereplacement procedure. For example, the anterior cruciate ligament andother ligaments may be repaired or reconstructed; quadriceps mechanismsand other muscles may be repaired. The patent documents mentioned aboveare hereby incorporated by reference.

In addition, intramedullary fracture fixation and comminuted fracturefixation may be achieved with the devices and methods of the presentinvention. For example, a plate or rod may be positioned within oragainst the fractured bone. A fastener may be driven through or aboutthe bone and locked onto the plate, rod, or another fastener.

It is further contemplated that the present invention may be used inconjunction with the devices and methods disclosed in U.S. Pat. No.5,329,846 entitled, Tissue Press and System, and U.S. Pat. No. 5,269,785entitled, Apparatus and Method for Tissue Removal. For example, animplant secured within the body using the present invention may includetissue harvested, configured, and implanted as described in the patents.The above-mentioned patents are hereby incorporated by reference.

Furthermore, it is contemplated that the methods of the presentinvention may be performed under indirect visualization, such asendoscopic guidance, computer assisted navigation, magnetic resonanceimaging, CT scan, ultrasound, fluoroscopy, X-ray, or other suitablevisualization technique. The implants, fasteners, fastener assemblies,and sutures of the present invention may include a radiopaque materialfor enhancing indirect visualization. The use of these visualizationmeans along with minimally invasive surgery techniques permitsphysicians to accurately and rapidly repair, reconstruct, augment, andsecure tissue or an implant within the body. U.S. Pat. Nos. 5,329,924;5,349,956; and 5,542,423 disclose apparatus and methods for use inmedical imaging. Also, the present invention may be performed usingrobotics, such as haptic arms or similar apparatus. The above-mentionedpatents are hereby incorporated by reference.

All references cited herein are expressly incorporated by reference intheir entirety.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed herein above. In addition, unless mention was made above tothe contrary, it should be noted that all of the accompanying drawingsare not to scale. A variety of modifications and variations are possiblein light of the above teachings without departing from the scope andspirit of the invention. Therefore, it will be understood that theappended claims are intended to cover all such modifications andembodiments which come within the spirit and scope of the presentinvention.

What is claimed is:
 1. A tensioning device comprising: a cannulated tubehaving opposite proximal and distal ends, and a longitudinal passageconfigured to enable an elongate member to be passed through thelongitudinal passage; a handle attached to the proximal end of thecannulated tube; and a rotatable shaft incorporated into the handlehaving an axis extending generally transverse to the longitudinalpassage and having an open ended slot, wherein the rotatable shaft isrotatably coupled to the cannulated tube and configured to beselectively rotatable about its axis relative to the cannulated tube,wherein the slot in the rotatable shaft is configured to receive theelongate member such that the elongate member wraps around the rotatableshaft as the rotatable shaft rotates about its axis to apply tension tothe elongate member.
 2. The tensioning device of claim 1, furthercomprising a locking assembly, wherein the locking assembly isconfigured to at least one of maintain the tension applied to theelongate member and prevent reversal of the rotatable shaft.
 3. Thetensioning device of claim 1, wherein the elongate member is comprisedat least in part of polyethylene.
 4. The tensioning device of claim 1,wherein the elongate member is at least one of a suture, a thread, acable, and a tape; and at least one of threadlike, multifilament,braided, and interlaced.
 5. The tensioning device of claim 1, whereinthe device is configured to be operated with a surgical roboticmechanism.
 6. The tensioning device of claim 1, further comprising atension limiting mechanism configured to restrict tensioning of theelongate member beyond a predetermined tension limit.
 7. The tensioningdevice of claim 1, wherein the tensioning device is configured to securea graft using the elongate member during anterior cruciate ligamentsurgery.
 8. The tensioning device of claim 1, further comprising a knobattached to the rotatable shaft.
 9. The tensioning device of claim 1,further comprising a tension indicator configured to indicate thetension being applied to the elongate member.
 10. The tensioning deviceof claim 9, wherein the tension indicator displays the tension measuredby at least one of a sensor and a spring.
 11. The tensioning device ofclaim 1, further comprising a crimping mechanism positionable in thedistal end of the cannulated tube, the crimping mechanism having atleast one force application member configured to apply at least oneexternal compressive force to reduce the aperture of a malleablefastener positionable in the crimping mechanism to secure the fastenerto the elongate member.
 12. The tensioning device of claim 1, whereinthe elongate member is configured to be secured to an anterior cruciateligament and the tension applied to the elongate member is configured totension the anterior cruciate ligament.
 13. The tensioning device ofclaim 1, wherein the elongate member is secured to an anterior cruciateligament graft and the tension applied to the elongate member tensionsthe anterior cruciate ligament graft.
 14. The tensioning device of claim1, wherein the elongate member is configured to be secured to a ligamentand the tension applied to the elongate member is configured to tensionthe ligament.
 15. The tensioning device of claim 1, wherein the elongatemember is configured to be secured to a rotator cuff tendon and thetension applied to the elongate member is configured to tension therotator cuff tendon.
 16. The tensioning device of claim 1, wherein theelongate member is configured to be secured to a tendon and the tensionapplied to the elongate member is configured to tension the tendon. 17.The tensioning device of claim 1, wherein the elongate member is securedto a graft and the tension applied to the elongate member tensions thegraft.
 18. The tensioning device of claim 1, wherein the elongate memberis secured to at least one of a fastener and an anchor and the tensionapplied to the elongate member applies a tension to the at least onefastener and anchor.
 19. The tensioning device of claim 1, wherein thetensioning device is configured to apply a tension to the elongatemember secured between at least one of a first fastener and a firstanchor and at least one of a second fastener and a second anchor. 20.The tensioning device of claim 1, further comprising a cutting mechanismconfigured to remove an excess of the elongate member.